Allergy Therapeutics plc
("Allergy
Therapeutics", "ATL" or the "Group")
Allergy Therapeutics provides
further detail from positive top line results from G306 Phase III
field trial to evaluate efficacy and safety of Grass MATA
MPL
- Statistically significant reduction in
Combined Symptom Medication Score (CSMS) seen in active treatment
group compared to placebo
- Sensitivity analyses of primary endpoint and
secondary endpoints show high consistency with primary endpoint
results
- The Group is preparing marketing
authorisation application (MAA) for planned submission in Q4
2024
7
May 2024 Allergy Therapeutics plc
(AIM: AGY), the fully integrated commercial biotechnology company
specialising in allergy vaccines, today provided further detail
from the positive top line results from its pivotal Phase III field
study G306 to evaluate the efficacy and safety of Grass MATA MPL,
the Group's short-course subcutaneous allergen-specific
immunotherapy (SCIT) candidate that aims to address the cause of
symptoms of allergic rhinoconjunctivitis due to grass
pollen. The trial successfully met its
primary endpoint as previously announced on 14 November
2023.
An evaluation was conducted in both
the EU and US to assess the impact of a treatment regimen
consisting of six pre-seasonal injections given over a span of 14
weeks. The key findings from this evaluation are as
follows:
· The
primary endpoint of the trial, "Combined
Symptom & Medication Score (CSMS)
averaged over the peak pollen season", demonstrated a statistically
significant improvement of 20.3% (p=0.00024) for Grass MATA MPL
compared to placebo, providing evidence of a substantial reduction
in daily symptoms and use of relief medication among participants
receiving Grass MATA MPL
· A
highly statistically significant improvement in the
rhinoconjunctivitis quality of life questionnaire (RQLQ) (p=0.0003)
was observed during the peak season
· The
protective biomarker immunoglobulin (IgG4), measured during the
grass pollen season, showed a large increase of approximately
five-fold after treatment with Grass MATA MPL compared to placebo
which achieved high statistical significance (p<0.0001)
consistent with data from the earlier G309 exploratory field
trial
· 555
subjects with allergic conjunctivitis and/or rhinitis were
randomised and 528 (95%) completed all six injections of Grass MATA
MPL or placebo. Demographics, allergic history and immunoglobulins
were generally well-balanced at baseline between the Grass MATA MPL
and placebo groups. In total, 278 and 277 patients received Grass
MATA MPL and placebo, respectively.
As previously communicated, the
treatment was well tolerated with no unexpected safety signals.
Further exploratory endpoint analyses (including an extensive
biomarker evaluation) of the G306 trial are now underway. Full
results, including secondary and exploratory endpoints, will be
presented at the upcoming European Academy of Allergy &
Clinical Immunology conference in June 2024 and submitted for
peer-reviewed publication later this year. The Group's preparation
for the marketing authorisation application (MAA) is well underway,
with a planned submission in Q4 2024.
Manuel Llobet, CEO at Allergy Therapeutics,
stated: "The findings announced today further
demonstrate the beneficial treatment effect of our Grass MATA MPL
immunotherapy candidate. Grass pollen, a common cause of seasonal
allergy, significantly impacts the lives of many people,
necessitating the development of new treatment
options.
"The results of our G306 study, alongside the results of our
earlier G309 exploratory field study, provide a strong and
consistent data package for progression to an MAA submission. This
affords us the potential to provide a unique offering to the market
as the only Grass SCIT product registered through the TAV programme
in Germany. I would like to express my gratitude to our team at
Allergy Therapeutics and our partners at multiple trial sites and
countries for their exceptional work and dedication to this trial.
A special thank you goes to the patients who participated in our
trial programme. Without their involvement, we would not be able to
bring these urgently needed treatments to the
market."
This
announcement contains inside information for the purposes of
Article 7 of Regulatory (EU) No596/2014.
- ENDS -
For further information,
please contact:
Allergy Therapeutics
Manuel Llobet, Chief Executive
Officer
Shaun Furlong, Chief Financial Officer
+44 (0)1903 845 820
Panmure Gordon
Emma Earl, Mark Rogers, Freddy
Crossley, Corporate Finance
Rupert Dearden, Corporate
Broking
+44 (0) 20 7886 2500
ICR
Consilium
Mary-Jane Elliott / David Daley /
Davide Salvi
+44 20 3709 5700
allergytherapeutics@consilium-comms.com
Notes for editors:
About Allergy Therapeutics
Allergy Therapeutics is an
international commercial biotechnology company, headquartered in
the UK, focussed on the treatment and diagnosis of allergic
disorders, including aluminium free immunotherapy vaccines that
have the potential to cure disease. The Group sells proprietary and
third-party products from its subsidiaries in nine major European
countries and via distribution agreements in an additional ten
countries. Its broad pipeline of products in clinical development
includes vaccines for grass, tree, house dust mite and peanut. For
more information, please see www.allergytherapeutics.com.
About Allergic Rhinitis
Allergic rhinitis and/or
rhinoconjunctivitis is a type I allergic disease to common
aeroallergens such as pollen, mould spores and house dust mite
residue. Seasonal allergic rhinitis is most commonly caused by
allergy to pollen from tree, grasses or weeds, while perennial
allergic rhinitis is most commonly associated with allergy to dust
mite residue, mould spores or animal dander
About Grass MATA MPL
Grass MATA MPL is being developed as
a pre-seasonal subcutaneous immunotherapy product for the treatment
of allergic rhinitis and/or rhinoconjunctivitis.
Grass MATA MPL contains an extract of
13 grass pollens modified with glutaraldehyde (allergoid) to reduce
the reactivity with immunoglobulin E (IgE) antibodies without a
reduction in other important immunological properties, such as
T-cell reactivity. The allergoid is adsorbed to L-tyrosine as a
depot adjuvant system formulation. Monophosphoryl lipid-A (MPL), is
included as an adjuvant to increase the immunogenic effect of the
immunotherapy and to enhance the switch from an allergen specific
helper T-cell Type 2 (Th2) to helper T-cell Type 1 (Th1) like
immune response.
More information about the Phase III
G306 Grass MATA MPL trial can be found on ClinicalTrials.gov
under the identifier NCT05540717.